Article Archive

Late-stage pharmaceutical development represents a critical juncture where years of research and substantial investment converge toward market approval. At this phase, unexpected obstacles can trigger cascading delays with significant financial implications for promising compounds. This article examines common pitfalls that…

The journey of a pharmaceutical compound from laboratory conception to market availability is a multifaceted process fraught with challenges. The answer to what are the 4 stages of drug development provides a useful framework. Among the four stages of drug…

Navigating the FDA regulatory action process presents unique challenges, and unexpected setbacks can stall even the most promising development programs. FDA Type A Meetings provide sponsors with an opportunity to obtain regulatory advice and timely feedback on critical issues affecting…

Bringing a new drug to market is a long and highly regulated process designed to ensure safety, efficacy, and quality. The pharmaceutical drug development process moves through multiple stages—beginning with drug discovery, advancing through preclinical and clinical research, and ultimately…

Patients with serious or life-threatening conditions often face limited treatment options, and waiting for new therapies can take years. The Breakthrough Therapy Designation (BTD) helps accelerate this process for drugs that show strong early evidence of being more effective than…

Cell and gene therapy development has entered a transformative era, bringing unprecedented challenges and opportunities in Chemistry, Manufacturing, and Controls (CMC). As these revolutionary treatments progress from clinical trials to commercial manufacturing, the future of CMC in cell gene therapy…